QC Associate Cover Letter

In response to your job posting for QC associate, I am including this letter and my resume for your review.

In the previous role, I was responsible for general supervision for cGMP suite cleaning and waste removal, stocking of consumables, and movement of raw materials and solutions within the cGMP suites.

Please consider my qualifications and experience:

• Laboratory equipment qualification (advantage)
• Knowledge of cGLP & cGMP (advantage)
• Chemical testings for intermediates/products/raw materials and utilities
• Chemical testings to support manufacturing processes/process validations
• Experience in a related biopharmaceutical GLP or GMP lab environment
• Test and analyze samples by running an ELISA, RIA or Multiplex immunoassay
• Document results of test samples that include calculating the data and submitting final reports in EXCEL
• Utilize technical knowledge and review of quality control data

I would like to submit my application for the QC associate opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for direct supervision of QC analysts performing routine GMP testing of potency, bioassay, ELISA and other related methods.

My experience is an excellent fit for the list of requirements in this job:

• Highly detail oriented with strong general laboratory skills and good organizational skills
• Third level qualification in a science discipline, preferably BSc in a chemistry subject
• Specialist knowledge of pharmaceutical operations within the regulated industry
• Excellent knowledge of laboratory practices and cGMP applicable to a pharmaceutical environment
• Logical and problem solving skills
• Analytical testing - ELISA, PCR, flow cytometry
• CGMP or GLP experience
• Provided successful resolution of lab problems, deviation investigations, and process improvements

I would like to submit my application for the QC associate opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for input and assistance in executing training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment.

Please consider my qualifications and experience:

• May participate in OpEx projects
• Initiate and participates in laboratory investigations (OOS/deviations/atypical results/invalid results) and assist in timely closure of lab investigations and CAPA
• Performs equipment calibration, maintenance and validation
• Participate in method transfer/verification/validation
• Experience in ELN development and validation will be highly regarded
• Practical experience with one of ELISA, Electrophoresis, Protein chemistry and Coagulation will be essential
• An understanding of either EP/BP/USP/ICH guidelines
• Experience working in a GxP environments (GLP, GCP, GMP)

I submit this application to express my sincere interest in the QC associate position.

In the previous role, I was responsible for expert technical support to maintain cGMP testing in support of out of specifications (OOS) investigations and Non-conformance investigations.

Please consider my experience and qualifications for this position:

• Experience in either a commercial or academic sphere is appropriate
• BA/BS Chemistry (flexible on any related science background w/ relevant experience.)
• Knowledge of FDA 21 CFR Parts 210/211 and Change Management/Documentation experience
• Relevant experience in reagent qualification, method validation and transfer
• Familiarity with the use of air sampling equipment, autoclaves, bioburden, and endotoxin testing
• Basic knowledge of cGMPs, GLPs, SOPs, USP and FDA requirements, good analytical and laboratory techniques
• Computer literate on Microsoft Office (Word/Excel)
• BS or higher in Biology, Microbiology or related field Fluent in English

Please consider me for the QC associate opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for ownership & leadership to all activities for the demonstration of cGMP understanding and compliance within their teams and the overall QC function.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Lab experience is key but the role itself is paper/desk based, very office oriented, working in tandem with a lab to generate, review, execute and file GLP documents
• Strong working knowledge of GLP
• Perform chemical analyses using various instrumental and non-instrumental methods
• Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage tasks, preventative maintenance)
• Excellent documentation and organizational skills are essential
• Bioburden and endotoxin samples
• GMP lab
• Sample collection and testing